inforMED
MalfunctionHIN

BPS300 BIPOLAR GRASPER

Received Apr 24, 2018

Report 3002770040-2018-12347 · MDR key 7455973

Device

Generic name

Bipolar Grasper

Model number

BPS300

Lot number

GML-00145

Product problems

  • Material Integrity Problem
  • Physical Property Issue
  • Torn Material
  • Material Integrity Problem
  • Physical Property Issue
  • Torn Material

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • Missing Value Reason
  • No Known Impact Or Consequence To Patient
  • Missing Value Reason

Narrative

Description of Event or Problem

A SLIVER OF BLACK COATING WAS FOUND IN THE PATIENT WHILE USING THE BIPOLAR. THE SLIVER WAS TAKEN OUT. SURGEON CONTINUED TO USE THE BIPOLAR AFTERWARDS. AFTER THE BIPOLAR WAS TAKEN OUT, THE GRASPER ON THE BIPOLAR APPEARED TO HAVE A MISSING PART OF THE COATING (SAME SHAPE AS THE SLIVER). OVERALL, THE SURGEON WAS HAPPY WITH THIS UNIT. NO COMPLICATIONS TO THE PATIENT. CUSTOMER DOES NOT STOCK THIS ITEM.